- Centers that are exempt from Institutional Review Board/Ethics Board (IRB/EB) review should follow their own institution’s policies for implementing Protocol 5.0.
- Centers that require Institutional Review Board or Ethics Board approval must provide documentation of IRB/EB approval notice prior to Monday, October 17, 2016 in order to access the web based data entry system.
New documents include:
- Protocol 5.0
- Manual of Operations and Procedures 5.0
- Record of Revisions
- List of New Elements Added with the Implementation of Protocol 5.0
- Stroke Scale Instructions
- National Institutes of Health Stroke Scale Questionnaire
The remainder of forms have not had content revisions but contain the updated version number and date.
Manual of Operations
- Appendix A - Adverse Event Definitions
- Appendix B - IRB Guidelines
- Appendix C - Patient Info Sheets and Consent Templates
- Appendix D - Site Registration Agreements
- Appendix E - Financial Disclosure and Conflict of Interest
- Appendix F - Quality of Life Questionnaires
- Appendix G - Trail Making Test (Part B)
- Appendix H - Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Appendix I - Stroke Scales
- Appendix J - Data Access Request
- Appendix K - Device Brand List
- Appendix L - Rosters and Contact Information
- Appendix M - Intermacs Users' Guide
- Appendix N - Pedimacs Users' Guide
- Appendix O - Profiles of Advanced Heart Failure
- Appendix P - Intermacs Data Collection Forms
- Appendix Q - Pedimacs Data Collection Forms
- Appendix R - Clinical Center Responsibilities for Medical Device Reporting
The Intermacs Regulatory Team is available to assist with any questions you may have.
The 2016 Quarter 1 Intermacs / Pedimacs Quarterly Center Reports will be uploaded to the Intermacs / Pedimacs Web Based Data Entry Systems (WBDE) the week of June 27, 2016. Site Administrators at centers with an “Active” status will be able to download these materials directly from the WBDE by clicking on the “File Delivery” page. Please share these reports with your site PI and VAD teams.
- Intermacs “Recent Year” Quality Assurance Report – In addition to the standard quarterly quality assurance report Intermacs has added a new report limited to patients implanted since the beginning of the last complete calendar year (January 1st, 2015). We hope this comparison using a contemporary cohort will facilitate tracking changes in patient population and outcomes at your site.
- Pedimacs Federal Partners Report - Intermacs is posting the new Pedimacs Federal Partners Report on the Intermacs website (www.intermacs.org/reports/public-statistical-reports). This report contains an overview of Pedimacs patient characteristics and outcomes for the entire registry.
For questions regarding reports please contact Maceo Cleggett (email@example.com). For questions regarding site datasets please contact John Pennington (firstname.lastname@example.org).
- Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)
- Outcomes of children implanted with ventricular assist devices in the United States: First analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)
- Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)
http://www.jhltonline.org/, May-2016 (Volume 35, Issue 5)
|Quarterly Report Distribution Schedule
Intermacs quarterly reports are distributed each quarter through the Web-Based Data Entry (WBDE) file delivery system. Reports are distributed three months after coverage stop date to allow complete data entry, data processing, and accuracy checks. Please send any questions and comments to Maceo Cleggett at email@example.com.
|Calendar Quarter||Coverage Stop Date||Distribution Date|
|Q1||March 31st||June 30th|
|Q2||June 30th||September 30th|
|Q3||September 30th||December 31st|
|Q4||December 31st||March 31st|
If a patient transfers his/her care, the last date of medical contact should be used as the transfer date. This could be either a date of the last clinic visit, hospitalization or phone call.
Please update your Apple IOS version of Duo Security from your current version to version 3.5.1. The update is available on the Apple iTunes store (Link Below)
This update will fix the protection of the Duo Mobile Security application.
Intermacs is sensitive to site and participant confidentiality. Please use a secure e-mail to communicate confidential information with Intermacs staff. If you do not have a secure e-mail available, contact us at firstname.lastname@example.org and request access to the Intermacs secure e-mail.
This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268201100025C.